Related Manuals for A.R.C. Laser CLASSIC 514
Summary of Contents for A.R.C. Laser CLASSIC 514
- Page 1 User Manual A.R.C. Laser GmbH Bessemerstr. 14 Tel.: +49 911 21779-0 info@arclaser.de 0123 D-90411 Nürnberg Fax: +49 911 21779-99 www.arclaser.de...
- Page 2 Tel.: +49 911 21779-0 Fax: +49 911 21779-99 service@arclaser.de Copyright © A.R.C. Laser GmbH. All rights reserved. This document contains confidential and copyrighted information and may only be used with the devices described herein. Reproduction is prohibited without written permission from A.R.C.
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Page 3: Table Of Contents
User Manual CLASSIC 514 August 2023 Introduction ............................5 Marking and symbols ........................ 5 Intended use ..........................6 General contraindications ......................6 Theory and technical set-up ...................... 7 Transport and storage ........................8 Shipping and unpacking the device ..................8 Return shipment ........................ - Page 4 User Manual CLASSIC 514 August 2023 Laser-Stop ..........................33 Switch Off ..........................33 6.10 Symbols........................... 34 Accesory L-ORD ..........................35 Transport and Storage ......................35 CE Regulations ........................35 Accessories ..........................35 Stickers and Labels ......................... 35 Operating conditions ....................... 36 Installation ..........................
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Page 5: Introduction
User Manual CLASSIC 514 August 2023 1 Introduction We thank you for having chosen our CLASSIC 514 and wish you every success in using this versatile laser system. The CLASSIC 514 laser generates a laser beam of high intensity, which can cause injuries if handled improperly. -
Page 6: Intended Use
User Manual CLASSIC 514 August 2023 1.2 Intended use is intended to be used to treat diseases of the eye. In particular The CLASSIC 514 diseases of the retina, which can be treated with coagulation and diseases in the anterior segment, which can also be treated by coagulation, or partial evaporation of tissue are indicated. -
Page 7: Theory And Technical Set-Up
Through special manufacturing processes of the semiconductor material, A.R.C. Laser is able to provide this laser system in its specific wavelength property. The systems respective maximum output power varies in height and is set by the user via the display - just like the pulse length and pulse pause. -
Page 8: Transport And Storage
User Manual CLASSIC 514 August 2023 2 Transport and storage We at A.R.C. Laser GmbH will make sure that the device is packed and transported with the greatest possible care. Before unpacking the laser, please check the packaging for damage and report any damage immediately to the shipping agent and A.R.C. -
Page 9: Return Shipment
The device will be shipped in a specially developed transport packaging. Please keep this. If you ship the device back to A.R.C. Laser GmbH, be sure to use the intended transport packaging. Normally, the CLASSIC is delivered together with the slit lamp. For... -
Page 10: Set-Up And Installation
Before the device is delivered, it must be ensured that the laser can be set up in a suitable location. The CLASSIC 514 should be operated in an easily accessible place. The laser should not be operated near a heater, since the device only works when the ambient temperature is not higher than 35°... -
Page 11: Reflecting Surfaces
User Manual CLASSIC 514 August 2023 3.2.3 Reflecting surfaces To avoid danger from reflected direct and scattered radiation, there must be no reflective surfaces in the room. These can be: • Mirrors • Pictures behind glass • Chrome surfaces •... -
Page 12: Safety Information
The CLASSIC 514 laser falls under laser class 4 according to EN 60601-2-22, EN 60825-1 respectively. Class 4 in the standard describes high-energy lasers and therefore special measures have to be considered befor use in order to ensure safe and trouble-free working with the device. -
Page 13: Eye Safety
When using the laser, only those laser safety glasses that are designed for the wavelength of 514 nm and on which both the CE mark and the appropriate protection level are noted. The following laser safety glasses from A.R.C. Laser GmbH are suitable for the CLASSIC 514: •... -
Page 14: Explosion And Fire Hazard
Permitted Maximum Radiation: 1.9*10 ³ Jm 4.7 CE-Regulations The laser system CLASSIC 514 has been approved by the notified body in accordance with the European Directive 93/42/EEC for medical devices. Accordingly, the device bears the CE mark CE 0123. The device has been checked for electrical and mechanical safety. All parts we use comply with the CE regulations or have been tested for approval or suitability by the notified body. -
Page 15: Protective Housing
Directive 2015/863/EU (RoHS 3). 4.9 Protective housing The CLASSIC 514 laser has a protective housing. It prevents radiation from the laser from escaping and protects users from touching live parts. This housing must not be removed. -
Page 16: External Interlock Switch
Make sure the switch stucks firmly to prevent unexpected system interlock problems. 4.12 Safety-Shutter / Aiming beam The CLASSIC 514 has an internal safety shutter. This shutter opens by pressing the READY button and allows the user to release laser radiation. -
Page 17: Lables And Markings
4.15 Lables and markings The CLASSIC 514 is provided with various warnings in accordance with European and worldwide guidelines to prevent the laser user from being exposed to laser radiation by negligence. The following labels can be found on the CLASSIC 514:... -
Page 18: Operating Conditions
The device is marked with an additional label, which indicate to respect the user manual. 4.16 Operating conditions The medical laser CLASSIC 514 is not suitable for use in connection with combustible gas mixtures of all kinds. The device is not approved for operation at altitudes above 2,000 m above sea level. - Page 19 User Manual CLASSIC 514 August 2023 recommended separation distances from portable mobile wireless communication devices, please refer Chap. 18.3 (ELECTROMAGNETIC PROTECTION - II) and 18.4 (RECOMMENDED PROTECTION DISTANCES). RFID systems shall not be used at separation distances less than 0.15 m from the device.
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Page 20: Advice For Users
5.2 Laser-Safety-Training The CLASSIC 514 laser is designed for medical users. It may only be used by personnel who have been instructed in its operation. The A.R.C. Laser GmbH recommends, in addition to the briefing, participation in seminars in which working with different laser systems is dealt with. -
Page 21: Instrument Table
(down arrow) until it comes to a complete stop. After calibration, the table is horizontal again. 5.4.2 Foot Switch (optional) An optional footswitch is available for your CLASSIC 514. This enables the laser to be shot by footswitch. File: User Manual_CLASSIC 514_rev5.docx... -
Page 22: Slit Lamp Adaption Of The Laser
August 2023 5.4.3 Slit lamp adaption of the laser The CLASSIC 514 is delivered as standard with the slit lamp PCL 5 SH of A.R.C. Laser GmbH and is connected with the slit lamp via a permanently installed adaption, the “Super View”. -
Page 23: Combinations
August 2023 5.4.4 Combinations The CLASSIC 514 can be used with the slit lamp PCL 5 SH of A.R.C. Laser GmbH. A.R.C. Laser has checked and controlled the compatibility of the products according to the guidance of the respective manufacturers; the installation is done according to the guidance documents. -
Page 24: Operation
User Manual CLASSIC 514 August 2023 6 Operation This part of the manual only describes the technical application of the device, without going into the medical application. You will receive separate application manuals from A.R.C. Laser GmbH, if needed. Settings and adjustments should only be made in accordance with the operating instructions. - Page 25 User Manual CLASSIC 514 August 2023 The front panel of the device consists the following controls and keys: Laser Stop Adjustment of pulse length with plus/minus Laser READY LED Adjustment of pulse pause with plus/minus Laser READY button Display Reduction of the aiming beam...
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Page 26: Preparation
A T T E N T I O N The CLASSIC 514 should not be operated for more than 5 hours at a time. Restart the laser after 5 hours at the latest so that it can carry out the system check during the start routine. -
Page 27: Programs And Settings
User Manual CLASSIC 514 August 2023 Password entry After the system check, you will be asked to enter a password. The factory set password is “0000”. After first input the password should be changed individually. Refer to chapter 6.4.1 to change the password. -
Page 28: Energy Settings
User Manual CLASSIC 514 August 2023 6.3.2 Energy settings The energy can be set using the rotary wheel. The following energy values [mW] can be chosen by the operator: 50 mW bis 200 mW in 10 mW steps 200 mW bis 500 mW in 20 mW steps... -
Page 29: Apl Mode (All Pulse Laser) (Optionally)
EXIT symbol, to leave the APL mode. When chosing the back symbol, the CLASSIC 514 remains in the APL mode. 6.3.6 Pulse counter The CLASSIC 514 sums up the tiggered pulses. When pressing the rotary wheel, the counter wil be set to 0 again. File: User Manual_CLASSIC 514_rev5.docx... -
Page 30: Other Settings
User Manual CLASSIC 514 August 2023 6.4 Other settings By pressing the right and left - / + key simultanousely will guide you into the submenu for the device settings. This is either possible in READY mode as well as in STANDBY mode. Please note, that the device will leave the READY mode, when the main menu is left. -
Page 31: Password
6.5 Laser STANDBY / READY Pressing the laser READY button activates the CLASSIC 514 and the READY LED is flashing for some seconds. When the LED lights up permanently, the laser is active and laser radiation can be emitted. -
Page 32: Release Laser Radiation
Press the READY button: the yellow LED flashes for some seconds and then changes to steady light. Treatment can start. The software of the CLASSIC 514 sums up the number emitted shots, which is permanently shown in the lower area of the display. -
Page 33: Laser-Stop
In general, the Laser-Stop should only be used in emergencies. 6.9 Switch Off The CLASSIC 514 can be switched of on the back of the device using the On/Off switch. Afterwards you should also switch off the main switch on the lifting table. -
Page 34: Symbols
User Manual CLASSIC 514 August 2023 6.10 Symbols Attention Display brightness (25 – 100%) Back (in APL Mode) Audio pitch (0 – 100) Delete (during entering password) Audio volume (10 – 100) Accept (during entering password) Aiming beam brightness (1 – 100) -
Page 35: Accesory L-Ord
Haag-Streit slit lamp or a previous version of the PCL 5 SH of A.R.C. Laser GmbH. The L-ORD is firmly attached to the CLASSIC 514. If the L-ORD is not used for a longer time, it should be stored in the provided stand. The laser radiation is transmitted via an optical glass fiber to the L-ORD: The glass fiber is located in the black connecting hose. -
Page 36: Operating Conditions
7.5 Operating conditions The L-ORD is used together with the CLASSIC 514. With regard to ambient conditions such as humidity and air pressure, please refer to chapter 4.16. Due to the internal design of the L-ORD, a maximum temperature of 30° C must not be exceeded when using the CLASSIC 514 and L-ORD combination. -
Page 37: Installation
August 2023 7.6 Installation The L-ORD is firmly attached to the fiber port of the CLASSIC 514. Please do not manipulate the connection. First of all, open the locking srew of the L-ORD. Afterwards, you can remove it from the stand. - Page 38 User Manual CLASSIC 514 August 2023 Place the L-ORD on the pin of the tonometer mounting base at the slit lamp, as shown in the image below. Turn the lockwing screw thight to fix the L-ORD. L-ORD swung out L-ORD swung in Working position –...
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Page 39: Operation
User Manual CLASSIC 514 August 2023 7.7 Operation The L-ORD consists of following components: Zoom optic Spot size adjustment 50 µm bis 500 µm Locking screw Horizontal alignment adjusting wheel Spot focus unit Vertical alignment adjusting wheel Deflection mirror Eye safety filter Spot size adjustment The laser spot size can be adjusted from 50 to 500 µm with the... -
Page 40: The Treatment
User Manual CLASSIC 514 August 2023 7.8 The Treatment The use of the L-ORD can also cause reflections of the aiming beam on the turning mirror, which can interfere during treatment. To avoid these reflections, you can attach the supplied cover for the turning mirror. -
Page 41: Technical Data
User Manual CLASSIC 514 August 2023 8 Technical data 8.1 CLASSIC 514 8.1.1 General Model CLASSIC 514 Diode laser Cooling Air internal Weight 3,3 kg Dimentions H 17 cm/B 25 cm/T 22cm with stand Control Option Buttons and rotary wheel 8.1.2 Laser Data... -
Page 42: Maintenance
User Manual CLASSIC 514 August 2023 9 Maintenance 9.1 Introduction The device was designed, developed and tested according to the latest technical knowledge. We have set the product life to 7 years. In addition, the availability of spare parts is guaranteed by us within a period of 10 years. However, in order to ensure that everything works properly, we have made it possible for you to carry out a visual check of the status indicators from the outside. - Page 43 User Manual CLASSIC 514 August 2023 The following care instructions can be carried out by the user. These serve to make your work easier. For cleaning, the system must be disconnected from the mains. Always use a damp, but never wet, soft cloth for cleaning and disinfecting.
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Page 44: Cleaning Of Accesories
User Manual CLASSIC 514 August 2023 9.4 Cleaning of Accesories 9.4.1 Foot switch The general cleaning instructions (see above) must be respected in any case. When cleaning the foot switch, prevent the penetration of water or cleaning agents. Never place the foot switch in water or cleaning agent, this could lead to a short circuit. -
Page 45: Error Detection
9.5 Error Detection In case of an error, you can use this manual to isolate the problem and, in some cases, even solve it yourselfIf the problem persists, please contact your local A.R.C. Laser authorized dealer for technical support. When an error occurs in the system, the error will be displayed along with a symbol to identify the error. -
Page 46: Disposal
Under no circumstances should the device be disposed of with domestic waste. A.R.C. Laser GmbH is happy to assist with the disposal of the system; Costs for the proper return of the laser to A.R.C. Laser GmbH is the responsibility of the customer. -
Page 47: Customer Service
10 Customer service 10.1 Warranty Information A.R.C. Laser GmbH grants you a two-year guarantee. Parts that have a defect will be replaced free of charge within two years. All add-on and purchased parts are exempt from this guarantee. Our guarantee extends to the repair or replacement of defective parts. -
Page 48: Guidelines And Manufacturers Declaration
User Manual CLASSIC 514 August 2023 11 Guidelines and manufacturers declaration 11.1 Electromagnetic Emissions The laser is intended for use in an environment as specified below. The customer or user of the laser should ensure that it is operated in such an environment. -
Page 49: Electromagnetic Immunity (1)
User Manual CLASSIC 514 August 2023 11.2 Electromagnetic Immunity (1) The laser is intended for use in the electromagnetic environment specified below. The customer or the user of the laser should ensure that it is used in such an environment. - Page 50 User Manual CLASSIC 514 August 2023 Only the voltage of a typical professional healthcare facility Power 0% UT; 250/300 cycles IEC 61000-4-11 may be used.It is recommended interruption at 0 and 180 level to use an uninterruptible power supply. NOTE: UT is the AC mains voltage prior to application of the test level.
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Page 51: Electromagnetic Immunity (2)
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CLASSIC 514, Conducted disturbance including cables specified by the variables, induced by 150 kHz to IEC 61000-4-6 manufacturer. -
Page 52: Recommended Separation Distances Between Portable And Mobile Rf Telecommunications Equipment And The Laser
User Manual CLASSIC 514 August 2023 11.4 Recommended separation distances between portable and mobile RF telecommunications equipment and the laser The laser is intended for use in an electromagnetic environment in which the RF disturbances are controlled. The customer or... - Page 53 User Manual CLASSIC 514 August 2023 Notes: File: User Manual_CLASSIC 514_rev5.docx...
- Page 54 User Manual CLASSIC 514 August 2023 Notes: File: User Manual_CLASSIC 514_rev5.docx...
- Page 55 User Manual CLASSIC 514 August 2023 Notes: File: User Manual_CLASSIC 514_rev5.docx...
- Page 56 A.R.C. Laser GmbH Bessemerstr. 14 D-90411 Nürnberg Tel: +49 911 21779-0 Fax: +49 911 21779-99 www.arclaser.de...